Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT03455803
Eligibility Criteria:
Inclusion Criteria:
* Patients have to stop proton pump inhibitors (PPI) therapy 1 month before enrollment in the study.
* To be eligible as LPR patients in our study, patients must have presented a RSI score \> 13 and a RFS score \> 7. These thresholds were highly correlated with pathological pH monitoring (pH \< 4)
Exclusion Criteria:
* Noncompliance for CPAP Use: According to the standard Medicare criteria to define CPAP compliance, the patients who demonstrated CPAP use ≥ 4 h/ night for ≥ 70% of the nights are considered compliant.
* Antireflux therapy during the period of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03455803
Study Brief:
Protocol Section:
NCT03455803